Operational Engagement With Patient Advocates
January 21, 2020
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Darshan: Hello everyone. Welcome to another episode of Darshan Talks. We have Trishna Bharadia with us again and I’m really excited because we had a whole conversation pretty recently around the practical considerations of being a patient advocate, and how people want to engage with patient advocates, what make it really difficult.
Darshan: But one of the things Trishna mentioned in the last conversation is the problems around informed consent and how they’ve gotten ridiculous to be quite honest. And a part of me as a lawyer believes that, that’s completely legitimate because we’re trying to protect the company.
Darshan: But then there’s the practical element of this. So Trishna, if you could introduce yourself and then sort of go off on what are some of the issues with informed consent and what might be some solutions if you will.
Intro: This is the Darshan Talks podcast, regulatory guy, irregular podcast with host, Darshan Kulkarni. You can find the show on twitter @DarshanTalks or the show’s website at darshantalks.com.
Trishna: My name is Trishna Bharadia, I’m from the UK and I’m a health advocate and patient engagement champion. So I work to get the patient voice heard louder, stronger and more effectively within the entire healthcare journey. And so in terms of particularly informed consent and patient information, leaflets when it comes to participating in clinical trials and research studies.
Trishna: So for me it’s very much… I mean to be honest, they’re too long, they’re too complex, the language that is used is far too complicated. And I take the attitude, yes, we need to have the legal protection, not just thought the sponsor, but for the patient as well.
Trishna: But at the end of the day, if a patient doesn’t understand what they’re signing and doesn’t understand the information being conveyed to them, then that document isn’t fit for purpose. So an example I was recently sent two patient information leaflets and informed consent forms for clinical trials that somebody that I know who lives with inflammatory bowel disease, that they had been sent by their doctor because at the moment there is two clinical trials that could potentially be a way forward for their own treatment.
Trishna: And they sent me these documents and say, “Could you have a read of them. I know you’re a health advocate and your obviously used to reading these documents and just let me know what you think.” Now for each study there was 30 plus pages to read through. The language was not patient friendly at all and the entire document was just, it was very complex.
Trishna: There was a lot of text in there so it looked completely overwhelming. And one of the studies in particular within the study itself, there was multiple branches, there was lots of sub studies going on within this clinical trial. And I came away from reading those two documents, well over 60 pages worth of information and I didn’t feel informed.
Trishna: I didn’t really understand what the trials were, what was involved in them and what the patient commitment would be. And to be a perfectly honest, they gave me a bit of a headache because language that was being used, was completely inappropriate for a lay person.
Trishna: And I came away and I thought to myself, well, I’m an experienced patient advocate. I’ve not understood it or I found it difficult to understand. I’ve come away feeling overwhelmed. Then how about your average patient who doesn’t know much about the research process, doesn’t know much about the drugs development process and possibly doesn’t even know a huge amount about their own disease.
Trishna: So actually that document wasn’t fit for purpose because the whole point of informed consent, is if somebody is giving their consent and says that they have understood what that basically getting themselves into and if that document doesn’t allow them to understand that then actually the documents completely irrelevant.
Darshan: It’s one of those funny things that you’re kind of getting into a piece that I just got recently involved with. I’ve got a client who is a clinical trial site dealing with individuals who speak a different language and they were the IRB approved, the informed consent form and the informed consent was being used because these people did speak English to a certain extent and the questions become did they speak English enough? And was that adequate because the site was helping them along.
Darshan: The question really becomes as you’re pointing out, are our sponsors enabling that type of behavior where sites are having to make do with what the documentation is given because it’s not patient responsive and you’re talking about it in the context of just the size and the share granularity and or [inaudible 00:05:39] language used, but there’s also a whole discussion on translations associated with it.
Darshan: My question for you is as we continue, what are solutions to make this better? I mean obviously we’ve got several goals here. One is to make sure the sponsor’s protected. Well you find out an interesting point which is making sure that the patient is protected and understands what they are getting themselves into.
Darshan: This is not a disclaimer document, this is a information document and how do you make sure that happens appropriately? I know for example, in India they’ve been talking about video informed consents, but is that necessarily the answer?
Trishna: So I think we need to look at a range of solutions and don’t, I mean something like video I think can definitely, yes, make things easier, something like that. It could also depend on the level of digital literacy of patients. I know that for example, if it was my mom, my mom prefers to have something which they, she can physically hold in her hand and she can read.
Trishna: Also it depends on how people are able to best process information as well. So I am the kind of person that, again, I prefer to read things. So even when I’m watching television or I’m watching a movie on my laptop, I always have the subtitles because for me I find it much easier to process information by reading it rather than listening to it.
Trishna: So I think the key here is to have a range of solutions so that patients are able to choose what is potentially going to be the best way for them to understand what’s being asked of them. I think really key here is to have patients engagement, have patients involved in the production of this information.
Trishna: So if it’s, for example, if it’s a written document, have patients review it. I’ve done that in the past. I have reviewed informed consent of patient information leaflet and often it’s kind of like translating a document because the people who are writing these documents they’re highly trained, they’re scientific, they’re science people and sometimes they forget what the language best language is to use when you’re talking to lay people.
Trishna: In this, the study documents that I refer to that I’ve recently read, it kept referring to adverse events. Well nobody outside of the industry knows what an adverse event is. So somebody reading that is going to start thinking, well I don’t actually know what that means.
Trishna: Also when they were talking about potential side effects, they weren’t explaining what those side effects were. So for example, if you talk about hypertension, high blood pressure in bracket, if you’re talking about things which you’ve got complicated medical terms, explain what does that actually mean for the patient?
Trishna: What is the impact if that could potentially have on the patient? And just generally talk simple things like talking in the active voice can help with understanding using infographics and tables in order to help and flow diagrams in order to help people visualize what might be expected of them.
Trishna: So if you have various tests being done at various points throughout the trial, maybe have a table which says week zero week one, week two, week three and have the tests listed. So there is actually easier for somebody to map out what their commitment is and what might be expected of them.
Trishna: All of these things can help to make the documents more simple. If you’re talking about videos, then again, language is really important. It’s really important to ensure that there is a diversity represented because again, people want to be able to relate and see themselves reflected in whatever they’re watching.
Trishna: Potentially, with a video you could actually walk somebody through the process. Now if they have to go for a screening process, you could actually have somebody going through that screening process so that people can understand, well this is what having your blood taken is going to involve.
Trishna: If you’ve got to give a urine sample or any kind of maybe you have to have a cheek swab or something like that, they can actually see exactly what tests are going to be involved. Again, you could do the same for the actual intervention itself.
Trishna: So if it’s going to involve going into the hospital and having an infusion, you could actually feel what will that hospital room potentially look like. What does the infusion look like, how does it get inserted into, for example, your arm, et cetera. That way people will fully understand what’s being asked of them and it will make it much more simple for them to be able to give their informed consent.
Trishna: It will truly be informed consent rather than what at the moment. I think sometimes happens is a bit, it’s very confused and people don’t necessarily really understand what they’re signing up for and many patients don’t necessarily have the confidence to ask more questions.
Trishna: They might be presented with this kind of a document and feel completely overwhelmed and say, “Actually I’m not like this isn’t for me. This is far too overwhelming and I’m just not going to participate.” Because that’s the easiest thing to do because they might not have the confidence to ask more questions of the medical team.
Darshan: So I think your point’s well made. I’m just going to keep my lawyer hat on as I continue this conversation, but there’s a part of me that goes, that sounds great from a patient standpoint, but I’m not thinking if I have to coordinate and make sure this happens, I need to have a video informed consent that I know exactly what’s in there that has to be approved and review and all those good things.
Darshan: I then need a potentially a written one, like you said, because different people learn different ways. I maybe even want an audio one, but then I have to synchronize it across all of them to make sure that they’re all saying the same thing. Because in the US as you know, someone might say you mentioned this adverse event in this version but not in that version.
Darshan: And then when it gets updated it becomes even more problematic. I guess my question is, is the informed consent document then goes from becoming a short well in one page document that is easy to produce and mass make, if you will, to a huge project by itself and would patients… Is there significant value to patients of doing that?
Trishna: I think, well I think that probably is for the pure reason that currently recruitment is one of the biggest challenges for successful clinical trials and one of the factors that influences that. The fact that at the moment patients aren’t, it’s not… Things aren’t being made easy for the patient.
Trishna: So if we can approach and we can sort of well solve in certain ways, one of those challenges, I think it will go in the long run, it will go towards making clinical trials much more successful at the end of the day.
Darshan: That’s a great point. So let me ask you a question that sort of dovetails from this, which is one of the things you’re, I know you are significantly aware of and we’ve talked about this before, is the whole lay summaries angle and how people are talking about plain language summary is a lay summaries to explain the results of the study.
Darshan: In your opinion, do you think that the informed consent should be tied to the lay summary or is it okay that don’t are not necessarily connected?
Trishna: No, I think to be honest, I think everything within a one particular clinical trial, everything should be tied together. I think it provides a more holistic experience. So yeah, they should be tied together and to be, if the lay summary is going to be produced, then again you need to have patient involvement, you don’t have this same kind of the same kind of processes in place to be able to produce a similar client of informed consent as you’re doing for the lay summary.
Trishna: So you need to make sure that it’s being produced to a certain format, to a certain template. You have patients reviewing that document. HCPs, healthcare professionals should can also be reviewing that document because also, I mean at the end of the day it’s the HCPs who often end up handing that document to the patient, so they need to also be able to feel any questions because for a patient, their first point of call is usually their doctor.
Trishna: So again, I think it should all be linked. Everything should be tied together so that the entire clinical trial experience becomes much more patient friendly and patient focused.
Darshan: So as we continue down this path and become more patient friendly and patient focused, do you believe that there are certain professions if you will, that are better suited for this? Is it, for example, the nurse coordinator, is it the principal investigator who is a physician? Is it pharmacist who might be trained or is it whoever’s willing to just listen? Is there no ideal if you will.
Trishna: Personally I think there’s a responsibility for every single person who’s involved in a trial. I think in terms of the front facing people then usually the nurses generally because they usually the ones who have the most kind of, they have the most involvement directly with the patients then they tend to be a very good so point of call.
Trishna: However, I think the responsibility lies with everyone to be honest, I think when sort of bordering on dangerous territory by saying, “Well only the nurse should be focusing on making the trial more patient focused and patient friendly and should be delivering that.”
Trishna: I think in order for it to truly become more patient focused, every single person who’s involved in the development of the trial has that responsibility because at the end of the day it’s something which if you want to make the trial successful, having it patient focused is what element of making a trial successful. So everyone has a vested interest in doing that.
Darshan: I agree with you 100%. Again, thank you so much Trishna, this was a much longer podcast than we normally would have done but thank you so much. This was fascinating.
Trishna: Pleasure.
Intro: This is the Darshan Talks podcast, regulatory guy, irregular podcast with hosts Darshan Kulkarni. Then you can find the show on Twitter @DarshanTalks or the shows website at darshantalks.com.
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